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Biomedical subjects

G Velikova

Publications and source records attributed to G Velikova.

At least 19 recordsLinked to original sources
PubMed2007

The initial development of an item bank to assess and screen for psychological distress in cancer patients.

Psychological distress is a common problem among cancer patients. Despite the large number of instruments that have been developed to assess distress, their utility remains disappointing. This study aimed to use Rasch models to develop an item-bank which would provide the basis for better means of assessing psychological distress in cancer patients.An item bank was developed from eight psychological distress questionnaires using Rasch analysis to link common items. Items from the questionnaires were added iteratively with common items as anchor points and misfitting items (infit mean square >1.3) removed, and unidimensionality assessed.A total of 4914 patients completed the questionnaires providing an initial pool of 83 items. Twenty items were removed resulting in a final pool of 63 items. Good fit was demonstrated and no additional factor structure was evident from the residuals. However, there was little overlap between item locations and person measures, since items mainly targeted higher levels of distress. The Rasch analysis allowed items to be pooled and generated a unidimensional instrument for measuring psychological distress in cancer patients. Additional items are required to more accurately assess patients across the whole continuum of psychological distress.

Adolescent↗
PubMed2006

The EORTC QLQ-HDC29: a supplementary module assessing the quality of life during and after high-dose chemotherapy and stem cell transplantation.

High-dose chemotherapy followed by haematopoietic stem cell transplantation can be associated with high physical and emotional distress levels and reduced quality of life. Systematic prospective measurement of impact of therapy on patient quality of life can aid treatment choices and provide better patient information. We describe the development of a high-dose chemotherapy questionnaire module to supplement the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30). Phases 1-3 of module development were conducted in United Kingdom, Germany, Austria and Norway, according to EORTC QOL Group guidelines. Forty-eight quality of life (QOL) issues were generated from the literature searches and interviews with health care professionals (n=24) and patients (n=92). This produced a 50 item provisional module. Further testing in 169 patients resulted in the QLQ-HDC29 module, containing 29 items, conceptualised into six multi-item scales and eight single items. The EORTC QLQ-C30, supplemented by QLQ-HDC29 will provide a comprehensive QOL measure for the international clinical trials of high-dose chemotherapy.

Adolescent↗
PubMed2006

Rasch analysis of the dimensional structure of the Hospital Anxiety and Depression Scale.

The Hospital Anxiety and Depression Scale (HADS) has been used extensively in cancer patients to identify psychological distress. Reports of the factor structure and screening performance of the instrument vary. Rasch models allow an assessment of the structure of a questionnaire by identifying item fit. Removal of misfitting items may improve both the dimensionality and efficacy of screening questionnaires. A Rasch analysis of the HADS-T and subscales was used to explore the factor structure, dimensionality and screening efficacy. A total of 1855 patients completed a touchscreen version of the HADS, including 381 patients who had received a psychiatric interview (SCAN/PSE). These data were analysed using Rasch models, and the screening efficacy at identifying cases of psychological distress and anxiety and depression evaluated. The results demonstrated that the structure of the HADS-T and subscales was unidimensional. Three items from the HADS-T, and one from each of the subscales demonstrated misfit. Screening efficacy for the HADS-T and subscales was modest. However, removal of misfitting items had little impact on screening, demonstrating that items could potentially be omitted, if required. The item range covered a narrow spectrum of psychological distress, predominantly higher levels of distress. Additional items have to be added if screening for moderate to mild distress is to be improved for cancer patients.

Adult↗
PubMed2005

Psychosocial difficulties, deprivation and cancer: three questionnaire studies involving 609 cancer patients.

The aim of the study is to investigate associations between deprivation and self-reported social difficulties and psychological distress in cancer patients. A total of 304 men and 305 women (age range 18-88 years) with a range of cancer diagnoses and living in a socially diverse region (Carstairs and Morris index) completed the Hospital Anxiety and Depression Scale and the Social Difficulties Inventory. Univariate analyses of variance revealed statistically significant differences in reported social difficulties between groups (F (67, 576)=2.4, P<0.0001) with stage of disease (F (5, 576)=7.6, P<0.0001), age (F (2, 576)=4.8, P=0.009) and to a lesser extent deprivation (F (1, 576)=4.0, P=0.048) making significant contributions. Significantly more social difficulties were reported by less affluent patients with locally recurrent disease or 'survivors'. No other interactions were found. Significant differences in levels of reported psychological distress were found between groups (F (67, 575)=1.723, P=0.001) for stage of disease, sex and deprivation but no interactions observed. In conclusion, deprivation is associated with reported psychological distress and, to a lesser extent, social difficulties. Patients at particular risk cannot be identified with confidence by socio-demographic and clinical means supporting the recommendation from National Institute for Clinical Excellence for provision of psychosocial assessment for individual cancer patients.

Adolescent↗
PubMed2005

Health related quality of life outcomes in cancer clinical trials.

Over the last decade, health related quality of life (HRQOL) investigations have become an increasingly important part of many cancer clinical trial research programs. This paper presents a review of all HRQOL studies published by the European Organisation for Research and Treatment of Cancer (EORTC), one of the largest clinical trials organisations in Europe. The findings highlight 24 clinical trials that have been published to date, enrolling over 9000 patients. HRQOL is fully integrated into EORTC phase III trials. In many trials, HRQOL provides a valuable source of additional information useful to both clinician and patient when making treatment decisions. Furthermore, several trials have found that the combined use of clinical information along with HRQOL data has led to the development of new standards of care in several different cancer sites. With more than 40 ongoing HRQOL studies in the EORTC, we expect HRQOL to play an even greater role over the coming decade in helping establish the optimal treatment and care approach for cancer patients.

Clinical Trials as Topic↗
PubMed2004

Breast cancer outcomes in South Asian population of West Yorkshire.

OBJECTIVE: To examine tumour stage at diagnosis, treatment, patient and provider delays to diagnosis/treatment and survival of South Asian patients with breast cancer in Yorkshire in comparison with the general population. DESIGN: Retrospective study, using Yorkshire Cancer Registry population-based data on breast cancer. Data on 16,879 women with breast cancer diagnosed between 1986 and 1994 was available, of which 120 patients were South Asian. All-cause survival, controlling for age, socio-economic profile, tumour stage and treatment was examined. Effects of ethnicity on tumour stage at diagnosis, treatment, patient and provider delays to diagnosis and treatment were described. Over the period 1986-1994, an increase in the number of registered South Asian patients with breast cancer was observed. South Asian patients were significantly younger at the time of diagnosis and presented with larger primary tumours. They received similar treatment to non-Asian patients, but a higher mastectomy rate was noted. South Asian patients' survival, after controlling for age differences was similar to non-South Asian patients. South Asian patients had a significantly longer patient-related delay between initial symptoms and presentation to GP and a slightly longer provider-related delay in time to diagnosis and treatment. In conclusion, outcomes of breast cancer treatment in South Asian patients were similar to non-Asian patients. Asian patients presented later to their GPs, with larger primary tumours and more frequently had mastectomy.

Adult↗
PubMed2003

Feasibility and compliance of automated measurement of quality of life in oncology practice.

PURPOSE: Systematic quality-of-life (QOL) assessment may have value in oncology practice by increasing awareness of a wide range of issues, possibly increasing detection of psychologic morbidity, social problems, and changes in physical status, and improving care and its outcomes. However, logistic problems are substantial. Automated systems solve many of these problems. We field-tested the feasibility and compliance that can be achieved using a computer touchscreen system in two consecutive studies. PATIENTS AND METHODS: In study 1, a prospective cohort of 272 patients was offered QOL assessment at each clinic appointment for 6 months. In study 2, all patients (N = 1,291) were offered QOL assessment as part of clinic routine during a 12-week period. RESULTS: In study 1, 82% of patients agreed to take part, but over time, compliance was poor (median, 40%; mean, 43%) and deteriorated with longer follow-up. In study 2, the overall compliance was greatly increased (median, 100%; mean, 70%), and compliance was retained over multiple visits. In study 1, compliance was better in younger patients, males, and socially advantaged patients, but was not affected by the presence of depression or anxiety, or QOL. In the second study, building on experience in the first study, data collection and storage in the computer system was excellent, achieving 98% of collected data stored in one center. In general, patients were comfortable with the computers and the approach. Data collection on the wards was more difficult and less complete than in clinics, especially for patients undergoing acute admissions. CONCLUSION: Feasibility with higher compliance was demonstrated in study 2, in which the data collection was integrated into routine care, and can be improved with further technical initiatives and education of staff.

Adult↗
PubMed2002

Anxiety disorders in cancer patients: their nature, associations, and relation to quality of life.

PURPOSE: We aimed to estimate the prevalence and types of anxiety disorders diagnosed according to standardized criteria in cancer patients, to compare screening tools in detecting them, and to examine their demographic, oncologic, and psychosocial associations. METHODS: In this cross-sectional observational study of 178 subjects with lymphoma, renal cell carcinoma, malignant melanoma, or plasma cell dyscrasia, we related responses to questionnaires (administered by computer touch-screen) measuring psychological symptoms, quality of life (QOL), and social support to standardized psychiatric interviews and cancer management. RESULTS: Forty-eight percent of subjects reported sufficient anxiety for anxiety disorder to be considered. At subsequent diagnostic interview, 18% fulfilled International Classification of Disorders, 10th Revision criteria for anxiety disorder, including 6% of patients who reported low levels of anxiety by questionnaire. When subjects reported anxiety by questionnaire, if disruptive somatic anxiety was present, this increased the probability of diagnosable anxiety disorder from.31 to.7. The most accurate screening questionnaires were the trait scale of the State-Trait Anxiety Inventory and the Hospital Anxiety and Depression scale. Female sex and negative aspects of social support were associated with anxiety disorder in multivariate analyses. Anxiety disorder was independently associated with a deficit in QOL, particularly insomnia. CONCLUSION: Anxiety symptoms are common in cancer patients. Screening by questionnaire seems to assess anxiety symptoms adequately but discriminates abnormal anxiety inadequately. To improve this, we may need to use criteria such as disruption from anxiety, as illustrated by the impact of anxiety disorders on QOL. There seem to be few oncologic variables that could target screening for anxiety disorders.

Adult↗
PubMed2002

Computer-based quality of life questionnaires may contribute to doctor-patient interactions in oncology.

It is well recognized that oncologists should consider patients' quality of life and functioning when planning and delivering anticancer treatment, but a comprehensive assessment of how a patient feels requires a thorough inquiry. A standardized measurement of patients' quality of life may support clinicians in identifying important problems for discussion during the limited time of the medical consultations. The aim of this study was to assess the feasibility of computer-administered individual quality of life measurements in oncology clinics with immediate feedback of results to clinicians and to examine the impact of the information on consultations. The study employed a prospective non-randomized design with pre-test post-test within subjects comparisons and involved three medical oncologists and 28 cancer patients receiving chemotherapy. The intervention consisted of completion of quality of life questionnaires before the consultations and informing clinicians of the results. The main outcome measures were patients' perceptions of the content of baseline and intervention consultations and satisfaction with communication. A qualitative analysis of clinicians' interviews was performed. When clinicians had the quality of life results they enquired more often about daily activities (Z= -2.71, P=0.007), emotional problems (Z= -2.11, P=0.035) and work related issues (Z= -1.89, P=0.058). There was an increase in the number of issues discussed during the intervention consultation (Z= -1.89, P=0.059). Patients were highly satisfied with both consultations. The computer measurement was well accepted by patients who felt that the questionnaires were a useful tool to tell the doctors about their problems. The clinicians perceived that the quality of life data broadened the range of the clinical inquiry and helped them identify issues for discussion. Having symptoms and functional problems expressed quantitatively on a scale was useful for detection of change over time.

Adult↗
PubMed2001

Validating automated screening for psychological distress by means of computer touchscreens for use in routine oncology practice.

The aim of the study was to confirm the validity of using touchscreen computers for screening for clinically significant levels of distress among cancer patients in routine oncology practice. The Hospital Anxiety and Depression Scale (HADS), EORTC Quality of Life questionnaire (QLQ-C30), Mental Health Inventory-MHI5 and a Concerns Checklist were administered via touchscreen computer to 172 chemotherapy out-patients, twice, 2-4 weeks apart. A standard psychiatric interview (Present State Examination - PSE) was conducted within a week of the second assessment. On interview, 23% of patients were identified as 'cases'. Using the available data (questionnaires, sociodemographic details, self-reported past psychiatric history), the best screening strategy combined scores from MHI-5 and HADS from a single time-point with the following rules: if MHI-5 < 11 = non-case; if MHI-5 > or = 11 then use HADS; then, if HADS > or = 9 = 'case' (sensitivity 85%; specificity 71%; misclassification rate 26%; positive predictive value 47%). The computerized screening system enabled data to be collected, scored, collated and reported in real time to identify patients who warrant further clinical assessment. It offers the potential for improving 'case' detection in routine oncology practice while reducing the burden of questions put to 'non-cases'. Further work is needed to develop optimal choice of screening questions for this purpose.

Depression↗
PubMed2001

Self-reported quality of life of individual cancer patients: concordance of results with disease course and medical records.

PURPOSE: To investigate the applicability of a standard quality of life (QL) questionnaire to individual cancer patients and to explore the potential for impact of QL information on the process of care by comparing at group level the QL results with the medical records. PATIENTS AND METHODS: One hundred fourteen consecutive patients at the oncology clinics at St James's Hospital, Leeds, United Kingdom, completed the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 on a touch-screen computer over a 6-month period. The QL results were compared with the corresponding medical records at individual and group level. RESULTS: For individual patients, the serial measurement of QL allowed recognition of patterns over time corresponding to disease course. At group level, a higher proportion of patients reported problems on EORTC QLQ-C30 than were mentioned in the medical records (McNemar paired test, P <.01). Most often clinicians mentioned pain (22% to 39%), and at the initial visit role (66%), and social issues (77%). For the rest of the symptoms and functions, the problems were recorded in between 1% and 25% of the notes, but 20% to 76% of the patients reported QL impairment. Problems that were not recorded in the medical notes tended to be of low severity, with a significant trend observed for pain, fatigue, nausea/vomiting, dyspnea, loss of appetite, and physical function scale (chi(2) test, 11.55 to 34.42, df = 1, P <.001). CONCLUSION: The QL data on individual patients was consistent with the clinical records, thus providing evidence for the validity of these measures in assessment of the individual. The QL profiles had more information on symptoms and particularly on functional issues, such as emotional distress and physical performance.

Disease Progression↗
PubMed1999

Quality of life instruments in oncology.

The objective of this article is to aid clinicians in understanding the current state of the development and application of quality of life (QOL) instruments as outcome measures in cancer clinical research and practice. As a result of the achievements of the past two decades, the concept of QOL has been defined and many reliable and valid measurement tools have been developed. The two main approaches to QOL assessment, psychometric-based and utility-based, are discussed together with a brief description of the strategies for meaningful interpretation of QOL profiles. QOL measures in oncology have the potential to be used to study populations in randomised clinical trials, to aid patient-clinician interactions in routine practice and to support policy decision making and economic evaluation of healthcare provision.

Clinical Trials as Topic↗
PubMed1999

Development of an EORTC questionnaire module to be used in health-related quality-of-life assessment for patients with multiple myeloma. European Organization for Research and Treatment of Cancer Study Group on Quality of Life.

A multiple myeloma-specific quality-of-life questionnaire module has been designed in collaboration with the EORTC Quality-of-Life Study Group to be used in clinical trials with the EORTC QLQ-C30, a general cancer questionnaire. Strict methodology was employed to ensure thorough and appropriate development of the module. An extensive literature review was performed to identify health-related quality-of-life issues relevant to patients with multiple myeloma. Semi-structured interviews were then carried out in several European countries with health-care providers experienced in the treatment of patients with multiple myeloma, and with a group of patients with multiple myeloma, to identify the issues which were most important to patients. A questionnaire was devised from the list of issues, using a 1-week time-frame and response categories consistent with the EORTC QLQ-C30. The provisional questionnaire and the EORTC QLQ-C30 were administered to patients with multiple myeloma in each participating country with further semi-structured interviews to refine the content and design of the questionnaire. A review of the results obtained in each stage of development resulted in a 24-item myeloma-specific module, the EORTC QLQ-MY24, which assesses disease-specific symptoms and their impact on everyday life, treatment side-effects, social support, and future perspective. The module is currently undergoing further international field-testing to assess its psychometric properties.

Adult↗
PubMed1999

Automated collection of quality-of-life data: a comparison of paper and computer touch-screen questionnaires.

PURPOSE: To evaluate alternative automated methods of collecting data on quality of life (QOL) in cancer patients. After initial evaluation of a range of technologies, we compared computer touch-screen questionnaires with paper questionnaires scanned by optical reading systems in terms of patients' acceptance, data quality, and reliability. PATIENTS AND METHODS: In a randomized cross-over trial, 149 cancer patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 2.0 (EORTC QLQ-C30), and the Hospital Anxiety and Depression Scale (HADS) on paper and on a touch screen. In a further test-retest study, 81 patients completed the electronic version of the questionnaires twice, with a time interval of 3 hours between questionnaires. RESULTS: Fifty-two percent of the patients preferred the touch screen to paper; 24% had no preference. The quality of the data collected with the touch-screen system was good, with no missed responses. At the group level, the differences between scores obtained with the two modes of administration of the instruments were small, suggesting equivalence for most of the QOL scales, with the possible exception of the emotional, fatigue, and nausea/vomiting scales and the appetite item, where patients tended to give more positive responses on the touch screen. At the individual patient level, the agreement was good, with a kappa coefficient from 0.57 to 0.77 and percent global agreement from 61% to 97%. The electronic questionnaire had good test-retest reliability, with correlation coefficients between the two administrations from 0.78 to 0.95, kappa coefficients of agreement from 0.55 to 0.90, and percent global agreement from 56% to 100%. CONCLUSION: Computer touch-screen QOL questionnaires were well accepted by cancer patients, with good data quality and reliability.

Adult↗
PubMed1998

Serum concentrations of soluble adhesion molecules in patients with colorectal cancer.

The concentrations of the soluble adhesion molecules E-cadherin, E-selectin, intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) were investigated in 48 patients with colorectal cancer before treatment, and their relation to clinical, histological and routine laboratory parameters was examined. Data were collected on tumour stage at presentation, presence and sites of metastatic disease, tumour pathology and results of routine laboratory tests. Serum concentrations of ICAM-1 and VCAM-1 were significantly elevated in the patients with colorectal cancer in comparison with a group of healthy subjects (P < 0.00001). Levels of circulating ICAM-1 and VCAM-1 were increased both in patients with local and those with metastatic disease. Although elevated in some patients soluble E-cadherin and E-selectin concentrations were not significantly elevated compared with the control group (P = 0.71 and P = 0.052 respectively). The levels of circulating ICAM-1 were significantly correlated with those of VCAM-1 and E-selectin. A correlation was also found between the serum concentrations of E-selectin and ICAM-1 and alkaline phosphatase, total white cell count and platelet count. VCAM-1 was positively correlated with age and negatively with degree of tumour differentiation and haemoglobin concentration. The biological implications and possible clinical relevance of these findings are discussed.

Adult↗
PubMed1997

Circulating soluble adhesion molecules E-cadherin, E-selectin, intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) in patients with gastric cancer.

The concentrations of the soluble adhesion molecules E-cadherin, E-selectin, intercellular adhesion molecule-1 (ICAM-1) and vascular cell adhesion molecule-1 (VCAM-1) were investigated in 45 patients with gastric cancer before treatment and their correlation with clinical, histological and routine laboratory parameters was examined. Data were collected on tumour stage at presentation, presence and sites of metastatic disease, tumour pathology, survival and results of routine laboratory tests. Serum concentrations of ICAM-1 and VCAM-1 were significantly elevated in the patients with gastric cancer in comparison with the group of healthy subjects (P < 0.00001 and P < 0.0001 respectively). Increased serum concentrations of VCAM-1 were associated with locally advanced and metastatic disease whereas ICAM-1 was significantly elevated both in local and in advanced/metastatic disease. Soluble E-cadherin and E-selectin concentrations did not show any significant elevation in gastric cancer patients. Concentrations of soluble adhesion molecules showed significant correlation with each other (except E-selectin and VCAM-1) and with alkaline phosphatase. Soluble ICAM-1 and VCAM-1 were significantly associated with an elevated total white cell count. Patients with elevated VCAM-1 had significantly poorer survival in comparison with patients with normal serum levels (P = 0.0361).

Adult↗
PubMed1996

A phase II study of interferon-alpha, interleukin-2 and 5-fluorouracil in advanced renal carcinoma: clinical data and laboratory evidence of protease activation.

OBJECTIVE: To confirm the activity and evaluate the toxicity of the combination of subcutaneous interferon-alpha (IFN-alpha) and interleukin-2 (IL-2) with intravenous 5-fluorouracil (5-FU) in patients with advanced and recurrent renal carcinoma and of performance status 0-2. Additionally, to examine protease, complement and neutrophil activation as potential mediators of IL-2 toxicity. PATIENTS AND METHODS: Fifty-five patients were treated in an 8-week cycle with IFN-alpha (6 MU/m2 on day 1 in weeks 1 and 4 and thrice weekly in weeks 2-3, and 9 MU/m2 thrice weekly in weeks 5-8) IL-2 (20 MU/m2 on days 3-5 in weeks 1 and 4 and 5 MU/m2 thrice weekly in weeks 2-3) and 5-FU (750 mg/m2 on day 1 of weeks 5-8). Patients responding to the first cycle were eligible to continue with further cycles. Toxicity and effects on quality of life were assessed using World Health Organization criteria and the Rotterdam Symptom Checklist and Hospital Anxiety and Depression Scale. Serum levels of C3a, prekallikrein and elastase-alpha 1 proteinase inhibitor (elastase-alpha 1-antitrypsin) were assayed in a subset of patients before, during and after the administration of high-dose IL-2 in week 1. RESULTS: There were partial remissions in nine patients, with responses in 24% (95% CI 10-38%) of evaluable patients and 16% of all patients. Amongst 25 evaluable patients who had undergone nephrectomy, the response rate was 32% (95% CI 14-50%), whereas there was only one response amongst 22 patients who had not undergone nephrectomy. The median survival for patients with stable disease or partial remission exceeded 22 months. Outcome and survival were related to performance status, number of sites of metastases and nephrectomy. This group of patients was of relatively poor performance status and 18 patients (36%) failed to complete one 8-week treatment cycle. Cardiovascular and renal toxicities were less than those seen with intravenous IL-2 schedules but 44% of patients experienced at least one grade III toxicity and only 14% reported less than two grade II toxicities. Plasma levels of elastase-alpha 1 proteinase inhibitor exceeded the normal range in three of seven patients tested before treatment and increased in all seven patients after treatment with IL-2. The same three patients had raised levels of C3a before treatment and in all patients examined, C3a increased after treatment with IL-2. In contrast, plasma prekallikrein concentrations were below normal before treatment and decreased further afterwards. CONCLUSIONS: This study confirms the activity of this regimen in patients of good performance status, with limited sites of disease and in those who are fit for nephrectomy, but also showed that treatment was associated with considerable toxicity. The administration of IL-2 is associated with protease activation which may be a suitable target for pharmacological intervention in attempts to ameliorate toxicity.

Adult↗